UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044371
Receipt number R000050682
Scientific Title The impact of organizational structure of intensive and high care units on in-hospital mortality: a retrospective analysis of Japanese administrative data
Date of disclosure of the study information 2021/05/31
Last modified on 2023/06/02 19:36:53

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Basic information

Public title

The impact of organizational structure of intensive and high care units on in-hospital mortality: a retrospective analysis of Japanese administrative data

Acronym

The impact of organizational structure of intensive and high care units on in-hospital mortality

Scientific Title

The impact of organizational structure of intensive and high care units on in-hospital mortality: a retrospective analysis of Japanese administrative data

Scientific Title:Acronym

The impact of organizational structure of intensive and high care units on in-hospital mortality

Region

Japan


Condition

Condition

patients in intensive and high care units

Classification by specialty

Anesthesiology Intensive care medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine in-hospital mortality among intensive and high care units in Japan.

Basic objectives2

Others

Basic objectives -Others

retrospective observational study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

in-hospital mortality

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients in intensive and high care units, and 18 years of age or more

Key exclusion criteria

death within admission day, and the cases that researchers judged to be inadequate

Target sample size

279370


Research contact person

Name of lead principal investigator

1st name Takeshi
Middle name
Last name Umegaki

Organization

Kansai Medical University

Division name

Department of Anesthesiology

Zip code

5731010

Address

2-5-1 Shin machi, Hirakata city, Osaka, Japan

TEL

072-804-0101

Email

umegakit@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Umegaki

Organization

Kansai Medical University

Division name

Department of Anesthesiology

Zip code

573-1010

Address

2-5-1 Shin machi, Hirakata city, Osaka, Japan

TEL

072-804-0101

Homepage URL


Email

umegakit@hirakata.kmu.ac.jp


Sponsor or person

Institute

Kansai Medical University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kansai Medical University Center for Ethical Review

Address

2-5-1 Shin machi, Hirakata city, Osaka, Japan

Tel

072-804-2440

Email

rinriirb@hirakata.kmu.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 31 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

279370

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2019 Year 09 Month 11 Day

Date of IRB

2019 Year 09 Month 11 Day

Anticipated trial start date

2019 Year 09 Month 11 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

retrospective observational study and duration from April 1, 2018 to March 31, 2019.


Management information

Registered date

2021 Year 05 Month 30 Day

Last modified on

2023 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050682


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name